FDA.reportPublic FDA data

Lacosamide

Product NDC
53746-926
11-digit product format
537460926
Labeler code
53746
Product ID
53746-926_9ae72ba8-4a6b-4d01-b73e-0f1c9ae18711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lacosamide
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204857
Marketing category
ANDA
Marketing start
2023-05-17
Substance
LACOSAMIDE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lacosamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACOSAMIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii563KS2PQY5
Rxcui809987, 809992, 809996, 810000

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac83aa9-21ef-4152-b501-369c0bc4765bProduct name120231010
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8c500b5-16db-e0e3-fdf1-c683d7be70e3Product name320161117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-926-05Lacosamide500 in 1 BOTTLETABLET5003
53746-926-60Lacosamide60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-926LACOSAMIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]3Current NDC, 2 package rows20240612_0e21389b-2f51-4975-aa21-fc5c9dd9f6dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809987lacosamide 100 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809992lacosamide 150 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809996lacosamide 200 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
810000lacosamide 50 MG Oral TabletPSN0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809987lacosamide 100 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809992lacosamide 150 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
809996lacosamide 200 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3
810000lacosamide 50 MG Oral TabletSCD0e21389b-2f51-4975-aa21-fc5c9dd9f6dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53746-926-0553746092605500 TABLET in 1 BOTTLE (53746-926-05) 500 tablet2023-05-17NoNoHistorical
53746-926-605374609266060 TABLET in 1 BOTTLE (53746-926-60) 60 tablet2023-05-17NoNoHistorical